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作 者:石婷婷[1,2] 葛卫红[1] 陈立兵[1] 付丹丹[1] 许广艳[1] 江叔奇[1]
机构地区:[1]浙江中医药大学,杭州310053 [2]浙江中医药大学附属杭州第三医院
出 处:《浙江中医药大学学报》2012年第1期64-66,共3页Journal of Zhejiang Chinese Medical University
基 金:"十一.五"国家科技支撑计划课题(2006BAI09B08-08)~~
摘 要:[目的]考察同一厂家不同批号五子衍宗丸的物质组释放特性,探讨高效液相(HPLC)检测方法在以多组分整体为评价对象的中药制剂体外释放特征研究的可行性及其特点。[方法]以HPLC为检测手段,超纯水为释放介质,在(37±0.5)℃温度下,采用浆法75r/min考察五子衍宗丸的多组分体外释放度特征。[结果]A厂生产批号为9035019.24,9035019.12,9035119.00的五子衍宗丸(水蜜丸)在120 min内物质组的平均累积释放百分率分别是92.44%,104.56%,88.57%;释放曲线的Weibull分布参数T50分别为(34.08±0.99)、(27.00±3.45)、(33.64±2.59)min,Td分别为(47.01±1.01)、(38.11±5.74)、(46.54±3.48)min。[结论]五子衍宗丸的多组分整体释放特征可用HPLC法进行研究。[Objective] To investigate materiomic release kinetic profiles of Wuzi Yanzong pills,which detected by HPLC.Moreover,to study the applicability and characteristics of HPLC on the research of Materiomic Release Kinetics of TCMs.[Method] To investigate the discrepancies in materiomic release kinetic profiles of Wuzi Yanzong pills of different batches produced by the same manufacturer by HPLC detection with the paddle method,water as release medium,75 r·min-1 rotation speeds,the temperature at 37±0.5℃.[Result] The relative materiomic accumulative release percentage of Wuzi Yanzong water-honeyed pills which manufactured by factory A with batch codes 9035019.24,9035019.12,9035119.00 were 92.44%,104.56% and 88.57% respectively,which released within 120 minutes.The average T50 of Weibull Distribution of the materiomic release profiles were 34.08±0.99,27.00±3.45 and 33.64±2.59 min respectively,and the average values of Td were 47.01±1.01,38.11±5.74 and 46.54±3.48 min respectively.[Conclusion] The HPLC detection methods of materiomic release kinetics of TCM can be applied to the study of materiomic release of Wuzi Yanzong pills.
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